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EMA Active Substance Guidelines

EMA’s Quality Working Party (QWP) has published a draft guideline on the CMC expectations for active substances and how to provide them in the 3.2.S section of the common technical document (CTD) in accord with ICH Q11 and other developments since the previous guidance was issued 28 years ago. Feedback will be accepted on the […]

EMA Q&A on Marketing Application Submissions

The European Medicines Agency (EMA) has updated a Q&A document to explain the role of its product teams in marketing application (MA) evaluation, what MA applicants can expect from the teams regarding preparation for clarification meetings, and what will be expected of them during the meeting. The product team is established during the pre-submission phase […]

Biosimilar Interchangeability in Finland

The Finnish Medicines Agency (FIMEA) has recommended that the Finnish healthcare system allow physician-authorized switching of branded products and their biosimilars. The agency cited evidence in its four-page report that no adverse events have yet been reported when such patient switches occurred. A similar recommendation was made by the Netherlands’ Medicines Evaluation Board (MEB) earlier […]

FDA Presence in China

FDA has been facing problems staffing its office in China due to difficulties in obtaining long-term working visas. While the intent has been to get 26 investigators in the two FDA offices in China (IPQ “Monthly Update” September 2011, pp. 27-24), the office currently has ten full-time employees, only three of whom are dedicated to […]

Supply Chain Security Pilot Program

In Mid-May, FDA announced that is looking for firms capable of developing and implementing a pilot program to “explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain” in accord with the Drug Supply Chain Security Act (DSCSA). The announcement is not a solicitation for applications, but rather an attempt […]

FDA Foreign Generic Drug Company Inspections

FDA has made “substantial improvements” to its inspections of foreign generic pharmaceutical manufacturers according to a new report by the Department of Health and Human Services’ (HHS) Office of the Inspector General (OIG). OIG’s early May report was prompted by congressional concerns that FDA lacked sufficient resources to inspect generic pharmaceutical manufacturers, which now make […]

Hamburg Joins IOM

In early April, the Institute of Medicine (IOM) announced that former FDA commissioner Margaret Hamburg has accepted a position as the foreign secretary of IOM. The part-time position, the announcement stated, will allow Hamburg to serve “as a senior adviser on international matters to the IOM president and council and as liaison to foreign academies […]

FDA Adopts ICH M7

In late May, FDA announced its adoption of ICH M7, “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.” M7 was finalized at the ICH meeting in Minneapolis, Minnesota in June 2014, and the Step 4 guideline was released in July. EMA formally adopted the guideline two months later. […]

Refuse to Receive Guidance Revision for ANDAs

In late May, FDA released a revision of its guidance on “Refuse to Receive [RtR] Standards for ANDA Submissions.” The changes include updating the previous version to account for CDER’s restructuring in the new Office of Pharmaceutical Quality (OPQ) and some information reorganization. The DMF assessment was removed from the RtR list. [For more on […]

IND Preparation Guidance

FDA announced in the Federal Register in mid-May the availability of a draft guidance on “Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators.” Released for a 60-day comment period, the draft is intended to assist applicants in the completion of INDs. The notice states that while it is not “an exhaustive step-by-step instruction manual,” […]
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